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Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

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NCT00275379

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Glendora, California, 91741 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Cystitis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects seeking medical treatment for symptoms consistent with IC that have been
ongoing for > 9 months or seeking medical treatment for a previous documented
diagnosis of IC

- Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months)
must agree and commit to the use of a medically acceptable, highly–effective (i.e.
double-barrier or IUD), non-hormonal form of birth control during the study and for 30
days after the last dose of test

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Use of herbal supplements (except for a daily multivitamin/mineral supplement not
containing herbal components)

- History of cancer (other than resected cutaneous basal or squamous cell carcinoma or
in situ cervical cancer) with less than 5 years documentation of a disease-free state

- Vaginitis or vaginal infection within 1 month before randomization

NCT00275379
Pfizer
Terminated
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

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Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041?s activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Cystitis, Interstitial
Drug: ERB-041
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
Not Provided
Not Provided

Inclusion Criteria:

  • Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
  • Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly?effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test

Exclusion Criteria:

  • Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
  • History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state
  • Vaginitis or vaginal infection within 1 month before randomization
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   United States
 
 
NCT00275379
3142A4-109
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Monitor For Germany, [email protected]
Principal Investigator: Trial Manager For Austria, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
March 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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